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Phase II Trial of RAD001 (Everolimus) in Previously Treated Small Cell Lung Cancer

Phase 2
18 Years
Not Enrolling
Small Cell Lung Cancer

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Trial Information

Phase II Trial of RAD001 (Everolimus) in Previously Treated Small Cell Lung Cancer

This is a phase II, two-stage, open-label, single-agent study of the experimental drug
RAD001 (everolimus) in patients with previously treated small cell lung cancer. Patients
may have received up to 2 prior chemotherapy regimens for small cell lung carcinoma, but no
prior therapy with an m-TOR inhibitor. RAD001 will be administered orally at a dose of 10
mg daily. A cycle will be defined as 3 weeks of study drug administration, and patients
will have tumor measurements every 2 cycles. Study participation will continue until
disease progression or intolerable toxicities. In addition, in patients who consent,
archival tumor tissue (paraffin block from original biopsy) will be collected for research

Inclusion Criteria:

1. Cytologically or histologically confirmed small cell carcinoma of the lung that has
progressed post first-line therapy. Mixed small and non-small cell tumors are

2. Prior chemotherapy for small cell carcinoma. Up to 2 prior chemotherapy regimens for
small cell lung carcinoma are allowed. No prior therapy with an m-TOR inhibitor (e.g.

3. Unidimensionally measurable disease (RECIST criteria). If the only site of
measurable disease is in a previously irradiated area, the patient must have
documented progression of disease in this area.

4. ECOG performance status 0-2.

5. A minimum of 4 weeks should elapse from prior chemotherapy. Patients must have fully
recovered from the effects of any prior surgery or radiation therapy or other
anticancer therapies, including immunotherapy and investigational agents.

6. No progressive brain metastases. Brain metastases should have been previously treated
with surgery and/or radiation.

7. Patients with a prior malignancy should have at least 3 years of disease-free
survival. Prior curatively treated squamous cell or basal carcinoma of the skin or in
situ cervical cancer or other in situ malignancies are allowed.

8. No other coexisting medical condition that would preclude full compliance with the

9. Required laboratory values (obtained < 1 week prior to enrollment):

- ANC >/= 1500/mm³

- Platelets >/= 100,000/mm³

- AST and ALT ≤ 3 x ULN (upper limits of normal). In patients with liver
metastases AST and ALT should be < 5 x ULN.

- Total bilirubin up to 1.5 x ULN (upper limits of normal).

10. Age >/= 18 years and capacity to give informed consent.

11. Patients should be advised to discontinue drugs that interact with CYP3A4 (see list
of examples in Table 3.1 of the full protocol), if medically safe.

12. All patients must have given signed, informed consent prior to registration on study.

Exclusion Criteria:

1. Prior treatment with any investigational agent within the preceding 4 weeks.

2. Other concurrent severe and/or uncontrolled medical disease which could compromise
participation in the study (i.e., uncontrolled diabetes, uncontrolled hypertension,
severe infection, severe malnutrition, unstable angina, or congestive heart failure -
New York Heart Association Class III or IV, ventricular arrhythmias active ischemic
heart disease, myocardial infarction within six months, chronic liver or renal
disease, active upper GI tract ulceration).

3. A known history of HIV seropositivity.

4. Impairment of gastrointestinal function or gastrointestinal disease that may
significantly alter the absorption of RAD001 (e.g., ulcerative disease, uncontrolled
nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection).

5. Patients with an active, bleeding diathesis or on anticoagulation (except low dose

6. Pregnant and lactating women are excluded from the study because the agents used in
this study may be teratogenic to a fetus and there is no information on the excretion
of the agents or their metabolites into breast milk.

7. Women of childbearing potential and sexually active males must agree to use an
accepted and effective method of contraception (hormonal or barrier methods,
abstinence) prior to study entry and for the duration of the study.

8. Patients should not be on chronic systemic glucocorticoids or other

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine the proportion of previously treated small cell lung cancer (SCLC) patients whose disease has not progressed following 6-weeks (2 cycles) of treatment with RAD001.

Outcome Time Frame:

Two cycles of treatment with RAD001 (~6 weeks)

Safety Issue:


Principal Investigator

Ahmad Tarhini, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Pittsburgh


United States: Food and Drug Administration

Study ID:




Start Date:

October 2006

Completion Date:

November 2012

Related Keywords:

  • Small Cell Lung Cancer
  • small cell
  • lung
  • Lung Neoplasms
  • Small Cell Lung Carcinoma



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